Trial Outcomes & Findings for Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China (NCT NCT01556165)

NCT ID: NCT01556165

Last Updated: 2014-12-23

Results Overview

The Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's disease-related disability and impairment. The scale comprises four parts: Part I evaluates mentation, behaviour, and mood symptoms; Part II evaluates activities of daily living (ADL); Part III evaluates motor function; and Part IV evaluates complications of dopaminergic therapy. The total score is the sum of the subscale scores for Parts I to III and ranges from 0 (no disability) to 176 (total dependence).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 130 participants
• Primary outcome timeframe: Baseline to Week 26
• Results posted on: 2014-12-23

Participant Flow

Outpatients aged 35 years or older, who had idiopathic Parkinson's disease and were not treated with levodopa or other antiparkinsonian medications, were recruited for this study from China.

A Screening Visit was held approximately 28 days prior to group assignment (group assignment was held during the Baseline Visit). Patients who met each of the inclusion criteria and none of the exclusion criteria were eligible to participate in this study.

Participant milestones

Measure	Placebo placebo: tablets, once daily, orally	Rasagiline rasagiline: 1 mg/day, tablets, once daily, orally
Overall Study STARTED	65	65
Overall Study COMPLETED	53	58
Overall Study NOT COMPLETED	12	7

Reasons for withdrawal

Measure	Placebo placebo: tablets, once daily, orally	Rasagiline rasagiline: 1 mg/day, tablets, once daily, orally
Overall Study Adverse Event	5	3
Overall Study Protocol Violation	0	3
Overall Study Withdrawal of Consent	7	1

Baseline Characteristics

Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China

Baseline characteristics by cohort

Measure	Placebo n=65 Participants placebo: tablets, once daily, orally	Rasagiline n=65 Participants rasagiline: 1 mg/day, tablets, once daily, orally	Total n=130 Participants Total of all reporting groups
Age, Continuous	59.5 years STANDARD_DEVIATION 9.22 • n=5 Participants	58.5 years STANDARD_DEVIATION 8.72 • n=7 Participants	59.0 years STANDARD_DEVIATION 8.95 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	30 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	35 Participants n=7 Participants	75 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	65 Participants n=5 Participants	65 Participants n=7 Participants	130 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 26

Population: The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.

The Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's disease-related disability and impairment. The scale comprises four parts: Part I evaluates mentation, behaviour, and mood symptoms; Part II evaluates activities of daily living (ADL); Part III evaluates motor function; and Part IV evaluates complications of dopaminergic therapy. The total score is the sum of the subscale scores for Parts I to III and ranges from 0 (no disability) to 176 (total dependence).

Outcome measures

Measure	Placebo n=63 Participants placebo: tablets, once daily, orally	Rasagiline n=64 Participants rasagiline: 1 mg/day, tablets, once daily, orally
Change From Baseline to Week 26 in UPDRS Total Score	-0.18 units on a scale Standard Error 0.98	-3.18 units on a scale Standard Error 0.95

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.

The Unified Parkinson's Disease Rating Scale (UPDRS) Part I evaluates mentation, behaviour and mood symptoms, it comprises 4 parts and the score ranges from 0 (normal) to 16 (severe impairement)

Outcome measures

Measure	Placebo n=63 Participants placebo: tablets, once daily, orally	Rasagiline n=64 Participants rasagiline: 1 mg/day, tablets, once daily, orally
Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part I)	0.08 units on a scale Standard Error 0.15	-0.54 units on a scale Standard Error 0.15

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.

The Unified Parkinson's Disease Rating Scale (UPDRS) Part II evaluates activities of daily living, it comprises 13 parts and the score ranges from 0 (normal) to 52 (severe impairement and disability)

Outcome measures

Measure	Placebo n=63 Participants placebo: tablets, once daily, orally	Rasagiline n=64 Participants rasagiline: 1 mg/day, tablets, once daily, orally
Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part II)	0.25 units on a scale Standard Error 0.38	-0.43 units on a scale Standard Error 0.37

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.

The Unified Parkinson's Disease Rating Scale (UPDRS) Part III evaluates motor function, it comprises 14 parts and the score ranges from 0 (normal) to 108 (severe impairement and disability)

Outcome measures

Measure	Placebo n=63 Participants placebo: tablets, once daily, orally	Rasagiline n=64 Participants rasagiline: 1 mg/day, tablets, once daily, orally
Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part III)	-0.52 units on a scale Standard Error 0.68	-2.23 units on a scale Standard Error 0.65

SECONDARY outcome

Timeframe: Baseline to Week 26

It was stated in the statistical analysis plan (SAP) that if >10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, time to onset of levodopa treatment was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Week 26

It was stated in the statistical analysis plan (SAP) that if >10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, levodopa administration within 26 Weeks was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

Rasagiline

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=65 participants at risk placebo: tablets, once daily, orally	Rasagiline n=65 participants at risk rasagiline: 1 mg/day, tablets, once daily, orally
Eye disorders Cataract	1.5% 1/65 • 30 weeks	0.00% 0/65 • 30 weeks
Injury, poisoning and procedural complications Road traffic accident	1.5% 1/65 • 30 weeks	0.00% 0/65 • 30 weeks
Injury, poisoning and procedural complications Thoracic vertebral fracture	1.5% 1/65 • 30 weeks	0.00% 0/65 • 30 weeks
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	1.5% 1/65 • 30 weeks	0.00% 0/65 • 30 weeks
Psychiatric disorders Major depression	1.5% 1/65 • 30 weeks	0.00% 0/65 • 30 weeks

Other adverse events

Measure	Placebo n=65 participants at risk placebo: tablets, once daily, orally	Rasagiline n=65 participants at risk rasagiline: 1 mg/day, tablets, once daily, orally
Injury, poisoning and procedural complications Accidental overdose	4.6% 3/65 • 30 weeks	6.2% 4/65 • 30 weeks
Nervous system disorders Parkinson's disease	6.2% 4/65 • 30 weeks	7.7% 5/65 • 30 weeks

Additional Information

Study director

Email contact via H. Ludbeck A/S

Email: LundbeckClinicalTrials@lundbeck.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place